Comparison of Intubation and Laryngeal Mask for Pars Plana Vitrectomy

NCT02778932 | Completed Results

• 1 other identifier: D 466/16
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

Pars plana vitrectomy is usually performed under general anesthesia including endotracheal intubation and muscle relaxation. However, for short procedures anesthesia using a laryngeal mask without muscle relaxation is also common in practice. In this observational study the incidence of patient movement will be examined between these anesthesia techniques.

Conditions

Muscle Relaxation

Outcome Measures

Primary Outcomes (1)

• Number of Patients Moving During Pars Plana Vitrectomy (Count of Participants)

  Movements of patients and abnormal deviations of eye position during surgery were reported to the anesthetist by the surgeon and noted by the anesthetist. Each patient with movement or abnormal deviations of eye position was counted as patient moving during pars plana vitrectomy (Count of participants). No score was used to report movement. Hence, no further score informations can be included.

  The estimated period of time over which the event is assessed is the time between incision and suture (estimated period of time: 30 - 180 min).

Secondary Outcomes (1)

• Quality of Immobilization

  The estimated period of time over which the event is assessed is the time between incision and suture (estimated period of time: 30 - 180 min).

Study Arms (2)

Intubation

General anesthesia including intubation and muscle relaxation

Laryngeal Mask

General anesthesia including laryngeal mask without muscle relaxation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing pars plana vitrectomy under general anesthesia

You may qualify if:

• Patients undergoing pars plana vitrectomy under general anesthesia

You may not qualify if:

• Age below 18 years

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

University Hospital Schleswig-Holstein

Kiel, Schleswig-Holstein, 24105, Germany

Location

Related Publications (3)

• Daien V, Turpin C, Lignereux F, Belghobsi R, Le Meur G, Lebranchu P, Pechereau A. Determinants of ocular deviation in esotropic subjects under general anesthesia. J Pediatr Ophthalmol Strabismus. 2013 May-Jun;50(3):155-60. doi: 10.3928/01913913-20130226-01. Epub 2013 Mar 5.

  PMID: 23451722 BACKGROUND

• Rossiter JD, Wood M, Lockwood A, Lewis K. Operating conditions for ocular surgery under general anaesthesia: an eccentric problem. Eye (Lond). 2006 Jan;20(1):55-8. doi: 10.1038/sj.eye.6701789.

  PMID: 15650757 BACKGROUND

• Spiteri N, Sidaras G, Czanner G, Batterbury M, Kaye SB. Assessing the quality of ophthalmic anesthesia. J Clin Anesth. 2015 Jun;27(4):285-9. doi: 10.1016/j.jclinane.2015.01.008. Epub 2015 Feb 18.

  PMID: 25704674 BACKGROUND

Results Point of Contact

• Title: Priv.-Doz. Dr. med. Axel Fudickar
• Organization: University Hospital Schleswig-Holstein, Campus Kiel

axel.fudickar@uksh.de

0049500

Study Officials

• Axel Fudickar, MD

  University Hospital Schleswig-Holstein

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Studienleiter

Study Record Dates

• First Submitted: May 8, 2016
• First Posted: May 20, 2016
• Study Start: May 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: June 16, 2021
• Results First Posted: June 16, 2021

Record last verified: 2021-05

Locations

DE (1)